Mara Vapor System

FDA Premarket Approval P160047 S014

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Changes in manufacturing to reduce the amount of copper on the printed circuit board assembly (pcba). These include a reduction in the amount of copper around the solder hole for the ground pin of the pcba-mounted pressure sensor and around non-plater thru holes (npth)

DeviceMara Vapor System
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantAEGEA MEDICAL , INC
Date Received2020-09-25
Decision Date2020-10-20
PMAP160047
SupplementS014
Product CodeMNB 
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address AEGEA MEDICAL , INC 2686 Middlefield Rd Suite A redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P160047Original Filing
S028 2022-12-21 30-day Notice
S027 2022-11-14 30-day Notice
S026 2022-01-05 30-day Notice
S025 2021-09-28 30-day Notice
S024 2021-04-01 30-day Notice
S023 2021-03-25 30-day Notice
S022 2021-03-23 30-day Notice
S021
S020 2021-01-06 30-day Notice
S019 2020-12-22 30-day Notice
S018
S017 2020-10-01 30-day Notice
S016 2020-10-01 30-day Notice
S015 2020-09-29 30-day Notice
S014 2020-09-25 30-day Notice
S013 2020-07-06 Real-time Process
S012 2020-06-22 30-day Notice
S011 2020-06-05 30-day Notice
S010 2020-04-07 30-day Notice
S009
S008
S007 2019-10-10 Normal 180 Day Track No User Fee
S006
S005
S004 2018-12-18 Normal 180 Day Track No User Fee
S003 2018-08-31 Normal 180 Day Track
S002 2018-08-27 30-day Notice
S001 2018-03-05 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00888937026887 P160047 000
00888937026870 P160047 000
00857379006030 P160047 006
00857379006023 P160047 006

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